Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-08-31

Brief Summary

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Safety and efficacy study of 25 and 50 mg doses of Proellex

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Detailed Description

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The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Conditions

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Uterine Fibroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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50 mg Proellex®

2, 25 mg capsules

Group Type ACTIVE_COMPARATOR

Proellex

Intervention Type DRUG

2, 25 mg capsules once per day

25 mg Proellex®

1, 25 mg capsule

Group Type ACTIVE_COMPARATOR

Proellex

Intervention Type DRUG

1, 25 mg capsule once per day

Interventions

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Proellex

2, 25 mg capsules once per day

Intervention Type DRUG

Proellex

1, 25 mg capsule once per day

Intervention Type DRUG

Other Intervention Names

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CDB-4124 CDB-4124

Eligibility Criteria

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Inclusion Criteria

* At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
* Subject has a menstrual cycle lasting from 20 to 40 days.
* Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria

* Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
* Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes